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This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) + N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo for the treatment of alcohol use disorder (AUD).
This is a pilot study designed to evaluate the safety, tolerability of Topiramate (TPM) + N-Acetyl Cysteine (NAC) in combination versus Topiramate (TPM) + placebo in 16 subjects enrolled in a 12 week, randomized, double-blind, outpatient trial. Each subject will receive randomly one of the drug combinations for 12 weeks plus medication management.
Primary Aim 1: To evaluate the safety, tolerability of Topiramate (TPM) and N-Acetyl Cysteine (NAC) in combination or Topiramate (TPM) + placebo for the treatment of Alcohol Use Disorder (AUD). This aim will be accomplished by testing the following:
•Hypothesis 1 - The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) will be well tolerated by participants as evidenced by less self-report cognitive side effects (word finding difficulties, difficulties with concentration, and confusion).
Secondary Aim 1: The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) or Topiramate (TPM) + Placebo will reduce alcohol drinking. This aim will be accomplished by testing the following:
•Hypothesis 2 - The combination of Topiramate (TPM) and N-Acetyl Cysteine (NAC) or Topiramate (TPM) + Placebo will reduced alcohol drinking , as evidenced by a statistically significant reduction in percentage of heavy drinking days (PHDD) as compared to baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate and N-Acetyl Cysteine | Experimental | Drug: Topiramate and N-Acetyl Cysteine Other Name for Topiramate: Topamax |
|
| Topiramate and Placebo | Experimental | Drug: Topiramate and Placebo Other Name for Topiramate: Topamax Other Name for Placebo: Sugar Pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate and N-Acetyl Cysteine | Drug | Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive side effects | Collection of self-report cognitive side effects | up to13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Heavy Drinking Days (PHDD) | The timeline follow-back (TLFB) method of measuring alcohol consumption will be used for Percent Heavy Drinking Days (PHDD). | up to 13 weeks |
| Drinks per Drinking Day |
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Inclusion Criteria:
Exclusion Criteria:
Please contact site for additional information
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| Name | Affiliation | Role |
|---|---|---|
| Nassima Ait-Daoud Tiouririne, M.D. | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UVA Center for Leading Edge Addiction Research | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| D000111 | Acetylcysteine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D002241 | Carbohydrates |
| D007661 |
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| Topiramate and Placebo | Drug | Topiramate up to 200 mg/day and Placebo for 12 weeks |
|
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Additional measures of self-reported drinking outcomes
| up to 13 weeks |
| Percentage of Days Abstinent | Additional measures of self-reported drinking outcomes | up to 13 weeks |
| Obsessive compulsive drinking scale (OCDS) | measurement of craving | up to 16 weeks |
| Drinking Inventory of Consequence (DrInC) scale | measurement of psychosocial consequences of drinking | DrInC is at screen, weeks 1,5,9, and 13 |
| Clinical Global Improvement (CGI) scale | Increase in overall clinical improvement | up to 16 weeks |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| Ketoses |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |